FDA Approval Insights: Glofitamab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma


Dr Carlo-Stella discusses the FDA approval of glofitamab in relapsed/refractory DLBCL, key efficacy and safety findings from the NP30179 trial, and the benefits of glofitamab’s mechanism of action.

Welcome to OncLive On Air®! I’m your host today, Ashling Wahner.

OncLive On Air® is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Carmelo Carlo-Stella, MD, PhD, about the FDA approval of glofitamab-gxbm (Columvi) for patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Dr Carlo-Stella is a full professor of hematology and the director of the Postgraduate School of Hematology at Humanitas University in Milan, Italy. He is also section chief of Lymphoid Malignancies and Cancer Therapeutics at Humanitas Clinical and Research Center – IRCCS, and has a teaching appointment in System Diseases 2 – Blood Diseases at Humanitas University Medical School.

On June 15, 2023, glofitamab received accelerated approval from the FDA for adult patients with relapsed/refractory DLBCL not otherwise specified or large B-cell lymphoma arising from follicular lymphoma who have received 2 or more prior lines of systemic therapy. This approval was supported by findings from the phase 1/2 NP30179 trial (NCT03075696), in which patients who received glofitamab achieved an objective response rate of 56% and a complete response rate of 43%.

In our exclusive interview, Dr Carlo-Stella discussed the significance of this approval, key efficacy and safety findings from the NP30179 trial, and the benefits of glofitamab’s mechanism of action in patients with DLBCL.


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